Medical Devices programme

TUESDAY, 3 OCTOBER

Registration, exhibition and refreshments

10.30-11.00


Introduction to Medical Devices Symposium

Presentation (PDF)

Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden

11.05


SESSION 1: Optimising the implementation of the new MDR

Leader: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden
Presentation (PDF)
An overview of the future regulatory framework and the key changes in the new Medical Device Regulation (MDR). What will their impact be on industry and how can organisations best prepare to deliver the new requirements within the timelines?

 

Chair: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden


 


Introduction

11.15

The new Medical Device Regulation
Presentation (PDF)
Erik Hansson – Deputy Head of Unit, Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, Health Technology and Cosmetics, European Commission

  • The new MDR – What does the new Regulation include?
  • Timelines for implementation
  • Development of guidelines.

11.20

Implementation challenges, how to prepare
Presentation (PDF)
Céline Bourguignon – Director Global Regulatory Policy, Johnson and Johnson, Belgium

  • Consequences for industry
  • Preparation
  • Transition period.

11.45

Panel discussion: “How to work together” moderated by Margareth Jorvid
This session’s speakers and speakers from Session 2 (Notified Body + Competent Authority) will take questions from the floor.


12.10


Lunch in Exhibition Hall

12.45


SESSION 2: Implications of new regulatory oversight requirements

Leader: Gert Bos, Qserve Group BV, the Netherlands

The new MDR changes supervision requirements both for notified bodies (NBs) and competent authorities (CAs). There are changes to setting up as an NB, conformity assessment routes and methods of practice. For CAs there are more specific requirements on supervision of NBs, market surveillance, and formulating and approving delegated and implementing acts, as well as common specifications.

 

Chair: Sabina Hoekstra – Philips, The Netherlands


Introduction
Presentation (PDF)
In recent years, additional instructions and guidance to notified bodies have been issued, resulting in stricter conformity assessment routes. In addition, the 2016 publication of the MEDDEV 2.7/1 rev.4 guidance on clinical evaluation has further enhanced the expectations to keep products on the market. Key players from CAs and NBs will explore their new level of expectations, and will provide guidance and explanations to the audience.


14.00


Impact on Notified Body
Presentation (PDF)
Giovanni Di Rienzo - Global director Cardiovascular Focus Team, TÜV SÜD Product Service, UK

  • Important steps towards a successful notification according to the new Regulation
  • Impact of the guidance document on the medical device manufacturer portfolio
  • New duties of the notified bodies during the approval process and post-market surveillance activities.

14.05


Impact on Competent Authority
Presentation (PDF)
John Wilkinson – Director of Devices Division, MHRA, UK

  • New responsibilities for competent authorities
  • Expanded or more specific extensions to current responsibilities
  • Role of CAs in more complex set of necessary collaborations across the system and the product lifecycle.

14.30


Panel discussion moderated by Sabina Hoekstra
This session’s speakers and speakers of Session 1 (Commission + Industry) will take questions from the floor.


14.55



Break

15.30


SESSION 3: Embracing the digital healthcare revolution

Leader: Tim Chesworth, AstraZeneca, UK

The effective use of apps, connected devices and other digital support services has the potential to have a profound and positive impact on patient outcomes. Regulators recognise this and are trying to adapt in a rapidly changing technological environment. Where do regulators and industry need to collaborate further to ensure patients can realise digital health benefits in a timely but safe and controlled manner?

 

Chair: Tim Chesworth, AstraZeneca, UK


 


Introduction

16.05

The future and challenges of software regulation
Presentation (PDF)
Valerie Field – Head of Devices Software/apps, Devices, MHRA, UK

  • Pace of new technology
  • Challenges for Regulation
  • Future guidance.

16.10

Industry challenges with medical device software
Presentation (PDF)
Kirsten Paulson – Pfizer, US

  • Development costs and timelines
  • Change control across countries and over time
  • MDR implementation.

16.30

Releasing software every week in a regulated environment
Presentation (PDF)
David Hubanks – Propeller Health, US

  • Agile development overview
  • Mapping agile to ISO 13485 & 21 CFR 820
  • Practical results (and the danger of too many doughnuts)
  • Improvement paths & next steps.

16.50

Panel discussion moderated by Tim Chesworth – This session’s speakers will take questions from the floor


17.10

End of Session 3 – Delegates move to Human Medicines Symposium


17.30


TOPRA Board update and student poster winners announced

17.35


Networking drinks in Exhibition Hall

Supported by Pharmalex

Following this, you're free to explore London.

18.15 – 19.15

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Programme subject to change.